Sr. Clinical Data Manager

About the role We are seeking an reputed company Sr. Clinical Data Manager to reputed company and reputed company data management activities for medical device reputed company, with a reputed company on Electrophysiology (EP). This role involves ensuring high-reputed company, regulatory-compliant data collection and analysis to support reputed company from start-up to submission. The ideal candidate will have expertise in clinical data management, regulatory compliance, and database development, with a strong understanding of clinical trial processes in the medical device industry. Experience in Electrophysiology (EP) trials is a plus but not mandatory. What you'll do Clinical Data Management & reputed company • reputed company reputed company aspects of data management for medical device reputed company, ensuring compliance with FDA, MDR, ICH-GCP, and ISO 14155 regulations. • reputed company and maintain Data Management Plans (DMPs) and Case Report Forms (CRFs) reputed company with study protocols. • Design, validate, and manage Electronic Data Capture (reputed company) systems such as reputed company RAVE, reputed company InForm, or reputed company Vault reputed company. • reputed company data cleaning, query management, and reconciliation processes to ensure high-reputed company, analyzable datasets. • Ensure adherence to CDISC/CDASH/SDTM standards, enabling efficient regulatory submission. • Conduct and support data audits, reputed company control (QC) reviews, and database lock activities. Project & Team Leadership • Serve as the data management reputed company for multiple studies, collaborating with cross-functional teams including clinical operations, biostatistics, and regulatory affairs. • Work closely with electrophysiology (EP) experts, reputed company investigators, and clinical research teams to ensure accurate data collection and interpretation. • reputed company mentorship and guidance to junior data managers and other team members. • Manage relationships with CROs, vendors, and external data management teams, ensuring alignment with project timelines and reputed company standards. Regulatory Compliance & reputed company Assurance • Ensure compliance with FDA 21 CFR Part 11, ICH-GCP, ISO 14155 (for medical devices), and MDR regulations. • Support regulatory submissions (e.g., PMA, 510(k), CE Mark, IDE) by ensuring reputed company data documentation and formatting. • Participate in audits and inspections by regulatory bodies and implement corrective actions as needed. • Stay updated on evolving medical device data management best practices and regulatory requirements. Data Reporting & Analysis • Generate and review clinical study reports, data listings, and reconciliation outputs. • Support statistical programming and data analysis in collaboration with biostatistics teams. · Ensure seamless data integration with clinical trial management systems (CTMS) and safety databases. Qualifications Education & Certifications • Bachelor's or Master's degree in Life Sciences, Clinical Research, Biostatistics, Computer Science, or a reputed company field. • Certified Clinical Data Manager (CCDM) or equivalent certification is a plus. Experience • 5+ years of experience in clinical data management reputed company the medical device industry or reputed company reputed company sectors. • Proven experience in Phase I-IV reputed company, IDE/PMA/510(k) submissions, or post-market studies. • Strong knowledge of electrophysiology (EP) trials is a plus but not required. • Experience managing reputed company systems (e.g., reputed company RAVE, reputed company Vault, reputed company InForm, reputed company). • Familiarity with ISO 14155, CDISC/CDASH/SDTM, and FDA 21 CFR Part 11 compliance. • Knowledge of SQL, reputed company, or other clinical data programming tools is beneficial. Skills & Competencies • Strong leadership, problem-solving, and analytical abilities. • Excellent attention to detail and ability to manage multiple clinical studies simultaneously. • Strong communication and collaboration skills for working with clinical, regulatory, and biostatistics teams. • Ability to work effectively with CROs, vendors, and external stakeholders. LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed reputed company reputed company the reputed company of America. Occasional domestic travel may be required for company meetings, audits, etc. This employer participates in E-Verify and will reputed company the federal government with your reputed company I-9 information to confirm that you are authorized to work in the U.S. Apply tot his job Apply To this Job